- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07775118
Comparative Study of Nasal Packing Duration: One-Day Packing Versus Three-Day Packing After Turbinate Surgery
Study Overview
Status
Intervention / Treatment
Detailed Description
Nasal obstruction is a common symptom that reaches 25% of the population worldwide. The main etiologies for nasal obstruction are septal deviation, hypertrophy of the inferior and middle turbinates, and nasal polyposis.
Hypertrophied inferior turbinate surgery techniques include Cauterization, Radiofrequency turbinate reduction, Coblation, Submucosal diathermy, Microdebrider and submucosal resection.
Endoscopic Partial inferior turbinectomy addresses both the hypertrophic mucosa and the underlying bone while leaving a normal-sized turbinate behind.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Al Gharbia
-
Tanta, Al Gharbia, Egypt, 31739
- Tanta University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged from 18 years to 45 years old.
- Both sexes.
- Patients with inferior turbinate hypertrophy.
- Following unsatisfactory medical treatment for at least three months.
Exclusion Criteria:
- Medically unfit patients (hypertensive and diabetic patients).
- Patients with bleeding tendencies.
- patients with Severe deviated septum.
- Congenital anomalies.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group (A)
Patients were scheduled for nasal packing for 1 day
|
Patients were scheduled for nasal packing for 1 day
|
|
Experimental: Group (B)
Patients were scheduled for nasal packing for 3 days
|
Patients were scheduled for nasal packing for 3 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative bleeding
Time Frame: Six months after surgery
|
Incidence of postoperative bleeding was recorded.
|
Six months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improvement in nasal obstruction
Time Frame: Six months after surgery
|
Improvement in nasal obstruction was assessed using the legalized Arabic version of the Nasal Obstruction Symptom Evaluation (Arabic NOSE) scale.
The Arabic NOSE scale consists of five items scored on a five-point Likert scale, with total scores extending from 0 to 100; developed scores indicate more severe nasal obstruction.
|
Six months after surgery
|
|
Bleeding during nasal pack removal
Time Frame: Intraoperatively
|
Incidence of bleeding during nasal pack removal was recorded.
|
Intraoperatively
|
|
Postoperative pain
Time Frame: Six months after surgery
|
Postoperative pain was judged utilizing the Visual Analogue Scale (VAS).
VAS is a straight 10-centimeter line where 0 means no pain and 10 means the worst pain.
|
Six months after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 36264MS764/12/24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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